AMS SPECTRA CONCEALABLE PENILE PROSTHESIS— 510(k) K082006
Substantially EquivalentAmerican Medical Systems, Inc.
FDA 510(k) clearance K082006 for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS, Substantially Equivalent on 2008-10-20. Applicant: American Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- American Medical Systems, Inc.
- Product code
- Code FAE
- Device class
- Class 2
- Regulation
- 21 CFR 876.3630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
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More clearances from American Medical Systems, Inc.
view allAdverse events under product code FAE
product code FAE- Injury
- 995
- Total
- 995
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.